MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-21 for DUBERSTEIN PHENOL APPLICATOR 130610 manufactured by Gyrus Acmi Inc..
[5178510]
Olympus was informed that while the physician was removing a rock from the patient's left ear, the tip of the device broke off. The physician flushed the patient's ear with antibiotic drops during irrigation and used a gentle suction. The intended procedure was successfully completed without injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
[12671050]
The device referenced in this report has not been returned to olympus for evaluation. The exact cause of the reported incident could not be conclusively determined at this time. If additional information becomes available at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2014-00613 |
| MDR Report Key | 4346800 |
| Report Source | 05,06 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-11-05 |
| Date of Event | 2014-10-02 |
| Date Mfgr Received | 2014-11-05 |
| Date Added to Maude | 2015-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NOEMI SCHAMBACH |
| Manufacturer Street | 2400 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE CA 951311700 |
| Manufacturer Country | US |
| Manufacturer Postal | 951311700 |
| Manufacturer Phone | 4089355002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUBERSTEIN PHENOL APPLICATOR |
| Generic Name | PHENOL APPLICATOR |
| Product Code | KCJ |
| Date Received | 2014-11-21 |
| Model Number | 130610 |
| Catalog Number | 130610 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI INC. |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772210 US 01772 2104 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-21 |